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The ARIX Ankle System is intended for use in internal fixation of the distal fibula.

The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes. The ARIX Ankle System is made of Unalloyed Titanium Alloy (Ti-6Al-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

This document describes a 510(k) premarket notification for the "ARIX Ankle System," which is a device for internal fixation of the distal fibula. The submission claims substantial equivalence to existing predicate devices.

Crucially, the provided text explicitly states there was no clinical study performed for this device, and therefore no data regarding AI performance, acceptance criteria for AI, or human reader studies.

Therefore, I cannot provide the requested information about acceptance criteria for AI, study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.

The relevant section from the document states:

"Clinical Test Summary
No clinical studies were considered necessary and performed."

This indicates that the FDA clearance for the ARIX Ankle System was based on non-clinical bench testing and a comparison of its technological characteristics and intended use to predicate devices, not on a study involving AI performance or human reader analysis.

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The ARIX Small Fragment System is intended for fixation of fractures, nonumons, replantations, and fusions pf small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

The ARIX Small Fragment System is composed locking bone plate and locking screws that provide rigid fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The ARIX Small Fragment System is made of Unalloyed Titanium and Titanium Alloy (Ti-6A1-V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The bone plates consist of Straight, Triangle and T type which has different lengths and number of plate holes. The bone screws are compatible with K201656 ARIX Elbow System Bone Screw previously cleared. The screws are 2.8mm in diameter with self-tapping and provided with lengths from 8.0 to 70.0mm.

This document describes the ARIX Small Fragment System, a medical device, and its acceptance criteria, but it does not include any information about a study proving the device meets acceptance criteria related to AI or algorithm performance.

The provided text is a 510(k) summary for the ARIX Small Fragment System, a metallic bone fixation appliance. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. This process typically involves comparing design, materials, indications for use, and performance, often through bench testing, rather than clinical efficacy studies or performance evaluations of AI algorithms.

Therefore, the following information you requested cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance (for an AI/algorithm device): This document discusses acceptance based on substantial equivalence to a predicate device and compliance with ASTM standards for metallic bone plates and screws. It does not provide acceptance criteria for an AI device.
• Sample size used for the test set and the data provenance: Not applicable, as no AI performance study is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does tell us about the device's "acceptance criteria" and "study":

The acceptance criteria for the ARIX Small Fragment System are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K063049 – Synthes Modular Mini Fragment LCP System) and compliance with relevant ASTM standards through bench testing.

Here's the relevant information from the document:

1. Acceptance Criteria and Reported Device Performance (as per the 510(k) process for this device type):

2. Sample size used for the test set and the data provenance:

• Test Set: The document refers to "bench tests" performed on the device. It does not specify the sample size (number of plates/screws tested) or data provenance (e.g., date of testing, lab location).
• Data Provenance: The tests were conducted internally by the manufacturer or a third-party lab to verify design specifications and compliance with ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of this type of bench testing. The "ground truth" here is compliance with engineering specifications and ASTM standards, which are objectively measured.

4. Adjudication method (for the test set):

• Not applicable. Results from mechanical bench tests are typically objective measurements against predefined thresholds, not subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states: "No clinical studies were considered necessary and performed."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a physical bone fixation system, not an AI algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" was defined by the design specifications of the device and the requirements of the ASTM standards (ASTM F382 and ASTM F543). The tests verified that the physical device met these objective, predefined engineering and performance criteria.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable.

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